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EDC & Clinical Data Solutions for Registries, RWE & Academic Research

Long-term research exposes weak infrastructure. Systems that work for a six-month trial start showing cracks three years into a registry or real-world evidence study, and by then the cost of switching is steep. Datatrak built its platform to avoid that problem altogether, pairing EDC with the rest of the eClinical toolkit in one connected system designed for long-term, large-scale, or investigator-initiated work.

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One Platform for Every Stage of Your Research

Datatrak gives registries, real-world evidence programs, and academic institutions one place to manage real-time data, whether that's a single investigator-initiated trial or a multi-year, multi-site registry. With drag-and-drop configuration, multiple controlled testing environments, and integrations, it’s built for how your team already works.

See How It Works

Three women in lab coats: Clinical research team reviewing study data together in a laboratory

FDA CFR 21
Part 11

Compliant

HIPAA

Compliant

GDPR

Compliant

GCP

Compliant

SOPs

Validated Systems

CDISC &
CDASH

SOC

Type II

EDC Built for Registries, RWE, and Academic Research

Long-term registries and real-world evidence studies need EDC software built to run for years, well past a typical enrollment window. The first EDC established in 1991, Datatrak is a proven, highly configurable system with the longest track record in life sciences. Research teams pick it up quickly because the interface is easy to navigate. It's validated and compliant with FDA 21 CFR Part 11, HIPAA, GDPR, and GCP, built to meet the requirements of registries, RWE, or academic protocol.

Centralized Data Oversight Across Every Site

Study planning, site performance, site communications, payments, all in one location, whether your research lives inside a single institution or spans a national registry network. No more switching between systems, no more piecing together the big picture.

Studies Built to Fit Your Needs

Configure the next registry, RWE, or academic study with drag-and-drop design tools across multiple controlled testing environments. Streamline the research and start enrolling participants sooner.

35+ years

of combined experience

10,000+ studies

managed by Fountayn

83+ countries

using Fountayn

"Datatrak is the best of breed products suite assisting in any clinical trials from simple to complex studies abroad oncology therapeutic area. It provides high speed connectivity for both sponsor and site users to enter eCRFs in a timely manner on intuitive UIs. The products have the capacity to allow pharmaceutical companies, CROs and Academic Institutes to build any type of clinical trials easily. It brings in cost efficiency and all features and built in a single platform. Datatrak is a powerhouse vendor in the health care industry."

Tsubasa Iwata — ClinCloud

We have been using Datatrak EDC for clinical data management for the past 10 years. It has been great working with the Datatrak team, their customer support always responds promptly and is super helpful. The system is easy to use, you can create customized forms, manage study participants, securely store and manage data.

Shannon Stoddard — Oculos

We have been using Datatrak for about 7 years now for our studies, and we selected Fountayn for several reasons. Basic functions to complex solutions are integrated into the same tool. It is user friendly, and site staff with experience know perfectly how to enter data, resolve queries, and more. Datatrak is friendly when exporting data to conduct statistical analysis. We have never had any downtimes or issues in our operations, and most importantly, we have never lost any data.

Alejandro Arias — CEO, ILS Clinical Research

We used Datatrak EDC to support a complex double-blind clinical trial, including custom randomization, a site-specific sub-study, and external imaging data entry. The platform handled edit checks and data validation reliably, with strong audit trails supporting compliance requirements. Its flexibility allowed us to adapt quickly as study needs evolved. We completed database lock on time with all SDV, and query resolution finalized, which speaks to both the system's robustness and how quickly our teams got productive on it.

Sandeep Saha — Director of Data Science, Cardiovascular Clinical Sciences

Tell us what you're trying to solve, and we'll show you how we can help.

Request a Demo

EDC & Clinical Data Solutions for Registries, RWE & Academic Research

One Platform for Every Stage of Your Research

EDC Built for Registries, RWE, and Academic Research

Centralized Data Oversight Across Every Site

Studies Built to Fit Your Needs

35+ years

10,000+ studies

83+ countries

Related Products

Electronic Data Capture (EDC)

Clinical Trial Management (CTMS)

Electronic Trial Master File (eTMF)

eConsent

Tell us what you're trying to solve, and we'll show you how we can help.